12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664114787·ANTI-EMB STOCKINGS THIGH HIGH CLOSED TOE SMALL-...
Bernafon
FDA UDI
Bernafon AG·05711584004609·CT9 M, VC PS SF BE CANTEO 9
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033818·Coupling Treatment Tube for 5F Flexibles (18)
I-STAT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023